Tracking acute treatment and long-term outcomes in children with meningitis
Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Children Meningitis
Hospital Israelita Albert Einstein · NCT07062445
This registry will collect care and outcome information to see how current treatments affect short- and long-term outcomes in children under 18 with suspected meningitis in Brazil.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Hospital Israelita Albert Einstein (other) |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07062445 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter clinical registry enrolling children under 18 with suspected acute infectious meningitis at roughly 20 public and private hospitals in Brazil. Clinical and laboratory data are recorded during hospitalization and follow-up visits occur at 28, 90, and 180 days after inclusion. Collected variables include timing and type of antibiotics, corticosteroid initiation, vaccination status, neurological sequelae, and access to rehabilitation services. Primary outcomes are all-cause mortality, hospital length of stay, rehospitalization rate, and incidence of sensorineural hearing loss, with additional etiology-specific and functional outcomes captured as secondary endpoints.
Who should consider this trial
Good fit: Children under 18 hospitalized at participating Brazilian sites with fever and the specified neurologic or meningeal signs (or age-specific presentations for infants) whose caregivers consent to participation are eligible.
Not a fit: Patients who decline consent, those treated outside participating hospitals, or children with noninfectious causes of neurologic symptoms are unlikely to benefit directly from the registry's findings.
Why it matters
Potential benefit: If successful, the findings could inform national care protocols and reduce mortality and long-term disabilities such as hearing loss among children with meningitis.
How similar studies have performed: Similar multicenter meningitis surveillance and registries have generated useful real-world data internationally, though large prospective pediatric registries in middle-income settings like Brazil are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fever (axillary temperature ≥37.8°C) followed by two or more of the following symptoms\*: severe headache, vomiting, altered consciousness (confusion, drowsiness, or irritability), photophobia (increased sensitivity to light), presence of seizures OR * Fever accompanied by at least one meningeal irritation sign, such as neck stiffness, Kernig's sign, or Brudzinski's sign OR * Sudden onset of fever and appearance of petechial skin rash or hemorrhagic suffusions * In children younger than two years, in addition to the presentations listed above, consider fever with any of the following: irritability, persistent crying, somnolence, or bulging fontanelle. Exclusion Criteria: * Refusal to provide consent for study participation
Where this trial is running
São Paulo, São Paulo
- Hospital Israelita Albert Einstein — São Paulo, São Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Anna M Gomes — Hospital Israelita Albert Einstein
- Study coordinator: Anna M Gomes
- Email: anna.gomes@einstein.br
- Phone: +55 11 2151-1233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Meningitis, Bacterial Infections, Viral Meningitis, Fungal Meningitis, meningitis, bacterial, virus, corticosteroids